NMR Diluent 1 - Sample Diluent 1 used for the Vantera Clinical - Labcorp of America

Duns Number:012822243

Device Description: Sample Diluent 1 used for the Vantera Clinical Analyzer.

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More Product Details

Catalog Number

9920030

Brand Name

NMR Diluent 1

Version/Model Number

9920030

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 19, 2019

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

CDT

Product Code Name

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Device Record Status

Public Device Record Key

504ab762-a091-4405-814c-8a173ac9cfc8

Public Version Date

September 25, 2019

Public Version Number

4

DI Record Publish Date

April 18, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LABCORP OF AMERICA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4